Zydus gets USFDA nod for generic version of anti-epilepsy drug

Eligible for 180 days shared exclusivity for Brivaracetam tablets.

October 06, 2022 11:06 am | Updated 01:11 pm IST

Representational image only.

Representational image only.

Drugmaker Zydus Lifesciences has received the United States Food and Drug Administration (USFDA) approval to market Brivaracetam tablets. 

An antiepileptic drug, the approved product is a generic of multinational pharma firm UCB’s Briviact. “U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received the final approval from the USFDA to market Brivaracetam Tablets USP 10mg, 25mg, 50mg 75mg and 100mg,“ Zydus said in a statement on October 6.

Since it was “one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Brivaracetam Tablets USP 10mg, 25mg, 50mg, 75mg and 100mg, it is eligible for 180 days of shared generic drug exclusivity,” it said. 

Zydus gets USFDA approval for generic drug

The approved drug had annual sales of $412 million in the U.S., the company said citing IQVIA numbers. Brivaracetam is indicated for the treatment of partial-onset seizures in patients four years of age and older. 

“The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad,” Zydus said. 

Top News Today

Comments

Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.

We have migrated to a new commenting platform. If you are already a registered user of The Hindu and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.